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Albumin To Enhance Recovery After Acute Kidney Injury

ConditionsAcute Kidney InjuryRenal Replacement TherapyHypotensionCritical Illness
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

Study objectives:

To determine whether, in critically ill patients with Acute Kidney Injury requiring renal replacement therapy (AKI-RRT), randomization to receive intravenous hyperoncotic albumin 20-25% (100 mL X two doses) compared to control/placebo normal saline boluses (100 mL X two doses) given during RRT sessions, leads to:

1. An increase in organ support-free days (primary outcome) at 28 days following randomization; and 2. An increase in RRT-free days (principal secondary outcome) at 28 days following randomization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old;

Admission to a critical care unit/intensive care unit (ICU) for > 24 hours;

Receiving vasoactive therapy AND/OR undergoing mechanical ventilation (including non-invasive mechanical ventilation (NIMV));

Immediate initiation of RRT for management of AKI is planned OR additional RRT sessions are imminently planned for patients who already received RRT during their ICU admission;

Disqualifiers

Initiation of RRT for reasons other than AKI (e.g. drug intoxication, hypothermia) ;

Known pre-hospitalization end-stage kidney disease;

Kidney transplant within the past 365 days;

Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 20-25% Albumin fluid (100 mL)

    Biological/Vaccine

    Participants will be randomized to receive albumin (20-25%) during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (i.e. for SLED sessions, at 0 and 4 hours; for IHD sessions, at 0 and 2 hours).

  • 0.9% Normal Saline (100 mL)

    Other intervention

    Participants will be randomized to receive normal saline 100 mL boluses during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (e.g. for 8 hour SLED sessions, at 0 and 4 hours; for 4 hour IHD sessions, at 0 and 2 hours; for CRRT, after starting/randomization then every 12 hours while continuing on CRRT).

Treatment groups

856 Participants
are divided into 2 treatment groups
Group A: 20-25% Albumin fluidActive comparator 1 intervention
Group B: Normal SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Organ-support-free days (OSFD)

Organ support-free days are defined as days that are both: 1) vasoactive therapy-free; AND 2) mechanical ventilation-free (including NIMV). For patients who die within 28 days following randomization, organ support-free days are counted as -1. An OSFD will be defined as the receipt of \< 2 hours of any vasoactive therapy provided by continuous infusion AND the receipt of \< 2 hours of either invasive or non-invasive mechanical ventilation, within a 24-hour period.

Time frame
28 days following randomization

Secondary outcomes

1

RRT-free days through day 28

For each patient, one point will be given for each calendar day that a patient was free of RRT. For patients who die within 28 days following randomization, RRT-free days are counted as -1. An RRT-free day will be defined as a 24-period in which \< 2hours of CRRT was received within a 24-hour period and no intermittent RRT sessions were started during the 24-hour period.

Time frame
Through day 28
2

Vasoactive therapy free days

For patients who die within 28 days following initiation of randomization, vasoactive therapy-free days are counted as -1. Vasoactive therapy-free days will be defined as receipt of \< 2 hours of any vasoactive therapy provided by continuous infusion within a 24-hour period

Time frame
Through day 28
3

Mechanical ventilation-free days

For patients who die within 28 days following initiation of randomization, mechanical ventilation-free days are counted as -1. Mechanical ventilation-free days will be defined as receipt of \< 2 hours of either invasive or non-invasive ventilation during a 24-hour period. Invasive mechanical ventilation is that provided via endotracheal tube (including tracheostomy). Noninvasive ventilation will be counted when more than 5 cm H2O of continuous positive airway pressure and more than 5 cm H2O of pressure support when deployed to avoid intubation. Other uses of noninvasive ventilation (eg, chronic nighttime use for chronic obstructive pulmonary disease) will not be counted.

Time frame
Though day 28.
4

ICU free days

For patients who die within 28 days following initiation of randomization, ICU-free days are counted as being -1. ICU-free days will be defined as admission to an ICU for \< 2 hours within a 24-hour period

Time frame
Through 28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Hospital Research Institute

Lead sponsor

The Physicians' Services Incorporated Foundation

Collaborator

The Kidney Foundation of Canada

Collaborator

The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant.

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Canadian Blood Services

Collaborator

Héma-Québec

Collaborator

Source ClinicalTrials.gov
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